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Improved quality of life with erlotinib in a randomised phase III study

ENSURE, a randomised, phase III study, met its primary endpoint of improved progression-free survival (PFS) with erlotinib vs. gemcitabine/cisplatin in Asian patients with epidermal-growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC). Quality of life (QoL) is important in assessing treatment benefit and its assessment in the ENSURE study is associated with improved domains that favour elotinib to gemcitabine/cisplatin. The findings were presented by Dr Yi-Long Wu of the Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences in Guangzhou, China, on behalf of researchers from multiple sites in Asia in a proffered papers session at the 4th European Lung Cancer Conference (26-29 March 2014, Geneva, Switzerland).

Previously, interim analysis from this study showed median PFS of 11.0 vs. 5.5 months (p < 0.0001) and updated analysis confirmed these data. The patients older than 18 years with histologically confirmed stage IIIB/IV EGFR mutation-positive NSCLC were randomised 1:1 to erlotinib or gemcitabine/cisplatin until progression and/or unacceptable toxicity. QoL examines the balance between treatment efficacy and tolerability and in the ENSURE study, the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire was used for its analysis. It comprises subscales on physical, emotional, social and functional well-being, as well as the lung cancer subscale (LCS).

Improved QoL was seen for first-line treatment with erlotinib versus chemotherapy in Chinese EGFR mutation-positive patients in the OPTIMAL trial. Improved QoL was also seen in Asian patients treated with first-line gefitinib versus carboplatin/paclitaxel in the IPASS trial. Improved QoL for erlotinib versus placebo has also been shown in the second-line setting using the EORTC QoL questionnaire.

QoL improvements across all functions

In the ENSURE study, the researchers calculated time to symptomatic progression defined by ≥3-point decline in LCS score from baseline. Time to deterioration in Trial Outcome Index (TOI) was defined as ≥6-point decline in LCS score plus physical and functional scores from baseline, and time to deterioration in QoL was defined as ≥6-point decline in TOI score plus social and emotional scores from baseline. Data cut-off was 19 November 2012.

The FACT-L questionnaire was completed in 99% of cases in erlotinib arm and 98% in gemcitabine/cisplatin arm at baseline. However, at week 48 the completion rate was 100% in erlotinib arm and 78% in gemcitabine/cisplatin arm, respectively.

According to the QoL assessment using the FACT-L questionnaire, erlotinib was associated with improved QoL compared with gemcitabine/cisplatin across all functions, including a significant delay in time to symptomatic progression and time to deterioration in TOI and QoL. The results from the ENSURE study provide further support for the use of first-line erlotinib in Asian patients with EGFR mutation-positive NSCLC. These results are in line with the QoL benefit seen in the OPTIMAL trial.

Dr Wu receives speaker fees from Roche, AstraZeneca, Eli Lilly, Sonofi and Pfizer, while the study co-authors Drs Chen and Zuo are employees of Roche Product Development in Asia Pacific, China. All other authors have declared no conflicts of interest.